radiation therapy with rapidplan knowledge-based planning vs human-driven planning for treatment of prostate cancer

Conditions: Prostate Carcinoma

Summary: this phase iii trial compares the effects of radiation therapy using rapidplan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. rapidplan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. giving radiation therapy with rapidplan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.

primary objective: i. to determine if rapidplan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (gu) and gastrointestinal (gi) adverse events at 3 months post-radiotherapy for prostate cancer. exploratory objectives: i. after completion of radiation therapy, determine the incidence of: ia. grade 2 or greater gu and gi toxicity at 3 months (common terminology criteria for adverse events \[ctcae\] version 5); ib. quality of life 3 months post-radiotherapy; ic. rate of achieving dose-volume constraints. ii. determine if there are any statistical differences in dose-volumes results with rapidplan knowledge-based planning. outline: patients are randomized to 1 of 2 arms. arm a (human-driven): patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. additionally, patients undergo magnetic resonance imaging (mri) pre-treatment and blood sample collection and positron emission tomography (pet) throughout study. arm b (knowledge-based): patients receive rapidplan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. additionally, patients undergo mri pre-treatment and blood sample collection and pet throughout study. after completion of study treatment, patients are followed up at 3 and 12 months then yearly for up to year 5.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years old * histologically confirmed prostate cancer * clinical or pathologic stages t1c-t3b, nx or n0-1, m0-1 (american joint committee on cancer \[ajcc\] criteria 8th edition \[ed\]) * planned definitive dose radiotherapy to the prostate or prostate bed * eastern cooperative oncology group (ecog) performance status 0-2 assessed within 90 days of enrollment * patients must sign institutional review board (irb) approved study specific informed consent * patients must complete all required pre-entry tests within the specified time frames * patients must be able to start treatment (radiation) within 180 days of study registration * in case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (pi) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome exclusion criteria: * previous pelvic radiation \> 5 gy * planned delivery of radiotherapy to pelvic lymph nodes * planned delivery of brachytherapy of the prostate * active rectal diverticulitis, crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and crohn's disease not affecting the rectum are allowed) * prior hip replacement or penile implant * major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study) * indwelling or intermittent urinary catheter use